NDC 76519-1001

Levofloxacin

Levofloxacin

Levofloxacin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Levofloxacin.

Product ID76519-1001_989e7994-d299-4a68-ae22-259fd0290a3e
NDC76519-1001
Product TypeHuman Prescription Drug
Proprietary NameLevofloxacin
Generic NameLevofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA076361
Labeler NameH.J. Harkins Company, Inc.
Substance NameLEVOFLOXACIN
Active Ingredient Strength500 mg/1
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76519-1001-3

3 TABLET, FILM COATED in 1 BOTTLE (76519-1001-3)
Marketing Start Date2011-11-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1001-1 [76519100101]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

NDC 76519-1001-4 [76519100104]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

NDC 76519-1001-5 [76519100105]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

NDC 76519-1001-2 [76519100102]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

NDC 76519-1001-3 [76519100103]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

NDC 76519-1001-7 [76519100107]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-22
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN500 mg/1

OpenFDA Data

SPL SET ID:398348ed-1b65-4109-9d0f-f9d8a7175d61
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199885

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    NDC Crossover Matching brand name "Levofloxacin" or generic name "Levofloxacin"

    NDCBrand NameGeneric Name
    0121-0872LevofloxacinLevofloxacin
    0143-9315LevofloxacinLevofloxacin
    0143-9316LevofloxacinLevofloxacin
    0143-9317LevofloxacinLevofloxacin
    0143-9720LevofloxacinLevofloxacin
    0143-9721LevofloxacinLevofloxacin
    0143-9722LevofloxacinLevofloxacin
    0143-9775LevofloxacinLevofloxacin
    0143-9776LevofloxacinLevofloxacin
    0143-9777LevofloxacinLevofloxacin
    0409-0528LEVOFLOXACINLEVOFLOXACIN
    0527-1948LevofloxacinLevofloxacin
    0781-5790LevofloxacinLevofloxacin
    0781-5791LevofloxacinLevofloxacin
    0781-5792LevofloxacinLevofloxacin
    0904-6351LevofloxacinLevofloxacin
    0904-6352LevofloxacinLevofloxacin
    0904-6353LevofloxacinLevofloxacin
    10544-143LevofloxacinLevofloxacin
    10544-245LevofloxacinLevofloxacin
    10544-451levofloxacinlevofloxacin
    68071-1860LevofloxacinLevofloxacin
    68071-3089LevofloxacinLevofloxacin
    68071-3051LevofloxacinLevofloxacin
    68071-1932LevofloxacinLevofloxacin
    68071-3091LevofloxacinLevofloxacin
    68071-3093LevofloxacinLevofloxacin
    68071-3166LevofloxacinLevofloxacin
    68071-3218LevofloxacinLevofloxacin
    68071-4101LevofloxacinLevofloxacin
    68071-3271LevofloxacinLevofloxacin
    68071-3236LevofloxacinLevofloxacin
    68071-4422LevofloxacinLevofloxacin
    68071-4340LevofloxacinLevofloxacin
    68071-4547LevofloxacinLevofloxacin
    68071-4623LevofloxacinLevofloxacin
    68071-4726LevofloxacinLevofloxacin
    68071-4512LevofloxacinLevofloxacin
    68071-4738LevofloxacinLevofloxacin
    68084-481LevofloxacinLevofloxacin
    68084-483LevofloxacinLevofloxacin
    68084-482LevofloxacinLevofloxacin
    68180-240LevofloxacinLevofloxacin
    68180-242LevofloxacinLevofloxacin
    68180-241LevofloxacinLevofloxacin
    68382-017levofloxacinlevofloxacin
    68382-015levofloxacinlevofloxacin
    68382-016levofloxacinlevofloxacin
    68382-989levofloxacinlevofloxacin
    68788-6938LevofloxacinLevofloxacin
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